MOSAIC® 305C219 (UDI 00643169594678)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169594678), received between Jul 16, 2020 and Oct 12, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (P990064); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 27 DAYS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SPONTANEOUS SUSTAINED VENTRICULAR TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 17921068 ↗
• InjuryJun 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 DAYS POST IMPLANT OF THIS 19MM BIOPROSTHETIC AORTIC VALVE IMPLANTED IN THE TRICUSPID POSITION OF A (B)(6)-OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12076081 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIOVENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 10302682 ↗
• InjuryJul 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT'S MOTHER THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 19MM BIOPROSTHETIC AORTIC VALVE IMPLANTED IN THE MITRAL POSITION OF A (B)(6)-MONTH-OLD PEDIATRIC PATIENT, THERE WAS A "PROBLEM WITH HIS MITRAL VALVE WHICH ULTIMATELY HE NEEDED A HEART TRANSPLANT". IT IS UNKNOWN IF THE MITRAL VALVE NOTED WAS THE PATIENT'S NATIVE VALVE OR THE BIOPROSTHETIC VALVE. IT WAS ALSO REPORTED THAT APPROXIMATELY 2 MONTHS PRIOR TO IMPLANT OF THE BIOPROSTHETIC VALVE, THE PATIENT'S PACEMAKER WAS REPLACED WHICH CAUSED "HEART FAILURE". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10281784 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990064. One submission often covers many models, so check the product and lot details in each record.

• Z-1881-2019 · May 21, 2019 · Terminated
  Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1880-2019 · May 21, 2019 · Terminated
  Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1225-2009 · Jan 26, 2009 · Terminated
  Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Medtronic Inc 710 M